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New treatment option for Moderate-to-severe Benign Prostatic Hyperplasia (BPH)
Official title Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fasting Conditions
ClinicalTrials.gov ID: NCT07643220
What this study is testing
What is Test Drug?
Test Drug is an investigational medicine, being studied as a potential treatment for moderate-to-severe benign prostatic hyperplasia (bph).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 54, men only. Healthy volunteers may be eligible.
You may be able to join if
- Healthy male adults aged ≥19 years and \<55 years at screening.
- Body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg/m².
- Clinically healthy based on medical history, physical examination, ECG, and laboratory test results, as determined by the investigator.
- Willing and able to provide written informed consent.
- Agrees to use medically acceptable contraception during the required study period.
You likely can't join if
- Use of medications known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or other medications that may...
- Participation in another clinical trial involving an investigational product within 6 months prior to the first dose.
- Whole blood donation within 8 weeks or component blood donation within 2 weeks prior to the first dose.
- History of gastrointestinal resection that may affect drug absorption.
- Known hypersensitivity to dutasteride, tamsulosin, or any component of the investigational product.
- History of psychiatric illness, or any condition considered unsuitable for study participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 19 years to 54 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.